Locking clip with trigger bushing

ABSTRACT

A safety shield incorporating a locking clip to prevent inadvertent sticks or punctures by a needle is provided. The needle can be a needle cannula or other piercing member, disposed in a sliding orientation in the safety shield, such that the needle slides within the locking clip between an aperture at a proximal end of the locking clip and a trigger hole at a distal end of the clip. Upon withdrawal of the needle after use, a binding orientation is triggered when the needle tip is withdrawn from the trigger hole, As further protection to the bi-directional lock afforded by the binding orientation, the needle is provided with a safety stop to prevent movement of the needle tip through the aperture. In other aspects, the safety shield includes a trigger bushing, in which the needle cannula is slidably received, that is sized larger than the aperture.

This application is a continuation application of co-pending U.S.application Ser. No. 11/895,597 filed Aug. 25, 3007 which claimspriority from U.S. Provisional Application Ser. No. 60/840,363, whichwas filed on Aug. 25, 2006 and which is a continuation-in-part of U.S.application Ser. No. 10/585,987 which was filed on Oct. 31, 2006, nowU.S. Pat. No. 7,736,332, which claims priority from PCT/US2004/036339,filed on Nov. 1, 2004, which claims priority from U.S. application Ser.No. 10/698,869, filed on Oct. 31, 2003, now U.S. Pat. No. 7,226,434.Each of these applications is incorporated herein in its entirety byreference for all purposes.

TECHNICAL FIELD

The present invention relates to safety devices for preventinginadvertent sticks and punctures by medical sharps, and moreparticularly, to a safety shield incorporating a locking clip with anintegral binding plate that provides a hi-directional lock for a needleor other medical sharp.

BACKGROUND

Shielding devices of various types have been used to prevent inadvertentor undesired sticks from a contaminated piercing member such as amedical needle. Some devices utilize a separate shielding cap mountedover the needle after use, while other devices employ pivoting shieldsor extensible shields. Undesirably, these devices often require thepractitioner to use both hands to manipulate or actuate the device.Other designs include retractable devices that have drawbacks such asexcessive length, as compared to traditional non-safety devices, andwhich may require manual activation.

It would be desirable to provide a safety shield and locking clipcapable of substantially preventing unlocking of the safety shield in abinding orientation, and thereby preventing unwanted needle exposure. Italso would be desirable to provide a clip triggering mechanisminterposed between the clip and the introducer needle/cannula, Such atriggering mechanism also is desirably configured to minimize slidingresistance between the introducer needle and the triggering mechanismwhen the locking clip is in the pre-actuated condition. The safetyshield, locking clip and related methods should overcome thedeficiencies of the presently available methods and systems.

SUMMARY

A locking clip, a safety shield incorporating the locking clip, andmethods of making and using the safety shield and locking clip aredisclosed. The safety shield is defined by a housing, and can beconfigured in a plurality of orientations, including at least a slidingorientation, in which a needle cannula is permitted to slide within thelocking clip, and a binding orientation, in which the needle cannula issubstantially restrained from proximal and distal movement in order toprevent re-exposure of the needle cannula after use, and thus preventinadvertent sticks and punctures by the needle cannula. As used herein,“proximal movement” or “motion in a proximal direction” refers to motionor movement that is generally toward a clinician, and “distal movement”or “motion in a distal direction” refers to motion or movement that isgenerally away from the clinician or in the direction of thepatient/subject.

As used herein, the terms “needle cannula” and “needle” are usedinterchangeably, and the needle cannula described with reference to thevarious embodiments can be replaced by a different type of needle, oranother piercing member. Also, as used herein, the terms “locking clip”and “clip” are used interchangeably, and in particular, refer to a clipconfigured for use with the safety shield of the present invention.

Various clips can be used in conjunction with the safety shield, inaccordance with the present invention. An exemplary clip can include afirst leg, a second leg, and an aperture disposed between the first andsecond legs. The aperture can be formed on an aperture plate, alsoreferred to herein as a “locking plate.” The locking plate isparticularly useful in the binding orientation for triggering abi-directional lock, which can substantially restrain proximal or distalmovement of the needle cannula. A distal end of the clip, i.e., thatportion which is farthest from the clinician, can be formed with atrigger hole, dimensioned for movement of the needle cannulatherethrough in the sliding orientation. The second leg of the clip caninclude[s] a bearing surface for engaging the needle cannula, and atleast one spring element, or a network of spring elements, to facilitateconvergent movement of the first and second legs.

The distal end of the clip also is formed with a clearance hole oropening. The clearance hole or opening is arranged with respect to thetrigger hole, such that when the clip is put into the bindingorientation, the needle cannula is disposed so as to be at leastopposite to the clearance opening. In particular embodiments, a portionof the distal end of the needle cannula is disposed within the clearanceopening or extends outwardly from the clearance opening. The clearanceopening or hole also is dimensioned so that the needle cannula does notcome into contact with edges of the clearance opening.

According to first and second examples or aspects of the clip of thepresent invention, the trigger hole is formed either as a separate holefrom the clearance opening, or alternatively, as adjacent to or at leastpartially connected to the clearance opening, where the clearanceopening can receive at least a portion of the needle cannula in thebinding orientation. In the first exemplary embodiment or aspect, thetrigger hole and the clearance opening constitute separate openings,thus forming a two-hole design such as that described in InternationalPublication No. WO 2005/042073 referred to hereinafter, the teachings ofwhich are incorporated herein by reference. In the second exemplaryembodiment or aspect, the trigger hole and the clearance opening have atleast some overlap, thus forming a single opening having a predeterminedshape. As described further herein, such an opening is dimensioned andshaped so the needle cannula is slidable within the clip until the clipis put into the binding orientation. Other variations of the clip arepossible, and the clip is not limited to the two-hole design or singleopening described herein.

When the clip is in the binding orientation, the clip is secured to theneedle cannula so as to form a bi-directional lock. In this way, thereshould be no relative movement between the clip and the needle cannulaalong the long axis of the needle cannula. In further embodiments, theclip and housing are respectively configured to cooperate so the clipremains engaged with or secured to the needle cannula even if theclinician or another attempts to move either the housing of the safetyshield or the needle cannula in either a proximal or distal direction.

Notwithstanding this, it is contemplated that efforts might be taken tointentionally overcome the bi-directional locking by the clip so as todefeat the needle stick protection afforded by the safety shield. Thus,and in a first exemplary embodiment of the safety shield, the needlecannula is formed so as to include a safety stop (also referred to as a“safety stop feature,” “stop member,” and “safety stop member”) locatednear or adjacent to a distal end of the needle cannula. The safety stopincludes any of a number of mechanisms or techniques known to thoseskilled in the art, which would prevent passage of the distal end of theneedle cannula through the aperture of the aperture/locking plate.

In further embodiments, the safety stop includes a localized depressedarea in the needle cannula that extends generally outwardly from theexterior surface of the needle cannula (e.g., depression formed bycrimping), an arcuate member secured about the exterior surface of theneedle cannula (e.g., ferrule or ring), or other types of surfaceartifacts that in effect create a projection extending outwardly from atleast one or more portions of the needle cannula exterior surface. Suchsurface artifacts, localized depressions, or arcuate members are sizedand arranged on the needle exterior surface so that they create a radialprojection from the exterior surface that is larger than the aperturehole in the aperture plate. In this way, even if one could create acondition that would momentarily allow the clip and needle to move withrespect to each other, the needle cannula safety stop and aperture platewould cooperate to prevent the needle cannula from moving in a proximaldirection or the safety shield housing moving in a distal direction toexpose the sharp end of the needle cannula.

According to a further aspect or embodiment of the present invention,the safety shield includes a clip according to the second exemplaryembodiment, a needle cannula having a stop member or feature and atrigger bushing. The stop member or feature can be formed in a mannersimilar to the safety stop described herein. In one embodiment thetrigger bushing, which can have a generally tubular configuration, isinserted in the trigger hole of the clip. The needle cannula is arrangedto pass through the trigger bushing and be slidable therein when thetrigger bushing is disposed within the trigger hole. The stop member isgenerally sized and arranged on the needle cannula so as to create aradial projection from the exterior surface of the needle cannula thatis larger than the lumen or inner diameter of the trigger bushing.

When it is desired to put the clip into the binding orientation, theneedle cannula is moved proximally with respect to the safety shield(e.g., the clinician pulls back on the needle cannula). When the needlecannula is moved such that the stop member on the needle cannulacontacts the trigger bushing, further relative proximal movement of theneedle cannula also results in such movement by the trigger bushing.When the trigger bushing passes through the trigger hole, the needlecannula passes through the opening between the trigger hole and theclearance opening, thereby causing the clip to transition from thesliding orientation to the binding orientation. In this way, the clip issecured to the needle cannula to form the bi-directional lock such thatthere is no relative movement between the clip and the needle cannula.

As indicated herein, it is contemplated that efforts might be taken tointentionally overcome the bi-directional locking by the clip so as todefeat the needle stick protection afforded by the safety shield. Assuch, in further embodiments, the trigger bushing is sized ordimensioned so at least a portion of the trigger bushing is larger thanthe aperture hole in the aperture plate. Thus, even if one could createa condition that would momentarily allow the clip and needle to movewith respect to each other, the trigger bushing and the aperture platewould cooperate to prevent the needle cannula from moving in a proximaldirection or the safety shield housing moving in a distal direction toexpose the sharp end of the needle cannula.

A method of using a safety shield according to the present inventionincludes steps of: providing a clip with at least a first leg having atrigger hole, a second leg, and an aperture disposed between the firstand second legs; connecting at least a portion of the clip to a catheterhub; receiving a needle in a sliding orientation through the catheterhub; withdrawing the needle from the catheter hub and through thetrigger hole, such that the portion of the clip becomes disconnectedfrom the catheter hub, and triggering a lock that restrains movement ofthe needle; causing further movement of the needle with respect to theclip; and stopping a distal end of the needle from moving beyond theaperture. According to the method, the needle can be provided with asafety stop that prevents movement of the needle through the aperture.In addition, a trigger bushing can be provided to slidably enclose atleast a portion of the needle and the trigger bushing being sized largerthan the aperture.

Other aspects and embodiments of the invention are discussed below,

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and desired objects of thepresent invention, reference is made to the following detaileddescription taken in conjunction with the accompanying drawing figureswherein like reference characters denote corresponding parts throughoutthe several views and wherein:

FIG. 1 is a cross-sectional side view of a safety shield including alocking clip according to a first exemplary embodiment of the presentinvention in the sliding orientation, where a catheter hub is coupled tothe safety shield housing;

FIGS. 2A-2D are cross-sectional side views of the safety shield andlocking clip of FIG. 1, where the catheter hub is released from thesafety shield housing, and so the locking clip is in the bindingorientation;

FIGS. 3A-3C are illustrations of various exemplary embodiments of asafety stop according to the present invention;

FIG. 4A is a cross-sectional side view of a safety shield and lockingclip in a sliding orientation according to a second exemplary embodimentof the present invention;

FIG. 4B is a perspective view of the safety shield and locking clip ofFIG. 4A;

FIG. 5A is a cross-sectional side view of the safety shield and lockingclip of FIG. 4A in a binding orientation;

FIG. 5B is a perspective view of the safety shield and locking clip ofFIG. 5A;

FIG. 6 is a cross-sectional side view of the safety shield and lockingclip of FIG. 4A in a binding orientation, in which the needle cannula isfurther withdrawn in the proximal direction, so the trigger bushingcontacts the locking plate;

FIG. 7 is a perspective view of the safety shield and locking clip ofFIG. 7;

FIG. 8 is a cross-sectional side view of the safety shield and lockingclip of FIG. 4A in a binding orientation, in which the needle cannula isfurther withdrawn in the proximal direction, so the trigger bushingcontacts a portion of the shield housing;

FIG. 9 is a perspective view of the safety shield and locking clip ofFIG. 6;

FIG. 10 is an enlarged perspective view of the first exemplaryembodiment of a locking clip according to the present disclosure shownin FIG. 1; and

FIG. 11 is an enlarged perspective view of the second exemplaryembodiment of a locking clip according to the present disclosure shownin FIG. 4A.

DEFINITIONS

The instant invention is most clearly understood with reference to thefollowing definitions:

As used in the specification and claims, the singular form “a”, “an” and“the” include plural references unless the context clearly dictatesotherwise.

As used herein, the term “subject” refers to a patient that receivesinfusions or has blood and/or fluid collected therefrom using acatheter, needle, or other device that includes a safety shield.

As used herein, the term “clinician” refers to an individual (e.g.,doctor, nurse, technician or other medical personnel) administering aninfusion, performing fluid sampling, installing or removing a needlecannula, and may include support personnel.

As used herein, the term “proximal” refers to a portion of a structurethat is closer to a clinician, and the term “distal” refers to a portionthat is farthest from the clinician.

DETAILED DESCRIPTION

A locking clip, a safety shield incorporating the locking clip, andmethods of making and using the safety shield and locking clip areprovided. The embodiments and examples of the locking clip, safetyshield, and related methods as disclosed herein are discussed in termsof medical piercing members such as, for example, hypodermic needles,etc. for infusion of intravenous fluids, medical infusion or fluidsampling, and more particularly, in terms of a safety shield and lockingclip used with a needle cannula that prevents hazardous exposure to aneedle tip, including, for example, inadvertent needle sticks. It isenvisioned, however, that the present disclosure finds application to awide variety of cannula needles and devices for the infusion ofpreventive medications, medicaments, therapeutics, etc. to a subject. Itis also envisioned that the present disclosure may be employed forcollection of body fluids including those employed during proceduresrelating to phlebotomy, digestive, intestinal, urinary, veterinary, etc.It is contemplated that the safety shield may be utilized with othermedical needle applications including, but not limited to, fluidcollection, catheters, catheter introducers, guide wire introducers,spinal and epidural, biopsy, aphaeresis, dialysis, blood donor, Veressneedles, Huber needles, etc.

A safety shield including a housing that supports a clip for restrictingmovement of a piercing member is described in PCT Application No.PCT/US2004/036339, published as International Publication No. WO2005/042073. PCT Application No. PCT/US2004/036339, filed on Nov. 1,2004 and its related U.S. patent application Ser. No. 10/698,869, filedon Oct. 31, 2003, are hereby incorporated by reference herein. Referencealso should be made to International Publication No. WO 2005/042073 forfurther details of the design and function of the locking clip andsafety shield not otherwise described herein.

An exemplary safety shield and clip are shown, for example, in FIGS.19-26 of International Publication No. WO 2005/042073(“the '073publication”). The clip is formed with a trigger hole in a distal endthereof, and an integral binding plate is located at a proximal endrelative to a clinician. The binding plate includes an aperture, whichdefines a sliding orientation (see FIG. 25 thereof), such that theaperture is configured for sliding movement of a needle cannulatherethrough, or a binding orientation (see FIG. 26 thereof), whichprovides a bi-directional lock that locks the distal end of the needlecannula in a protected configuration. As described in the '073publication, the binding orientation is actuated when the tip of theneedle cannula passes through the trigger hole in the distal end of theclip and the locking clip is secured to the needle cannula such thatthere is no further relative movement between the needle cannula and thelocking clip. Thus, as the locking clip is disposed within the housingof the safety shield, the clinician or another is thereby shielded froman inadvertent needle stick.

As also described in the '073 publication, the safety shield is designedso relative movement by one or both of the housing and the locking clipin either or both the proximal or distal directions after thebi-directional lock is established, does not cause the locking clip tobecome disengaged from the needle cannula (i.e., the needle cannula doesnot slide or move with respect to the locking clip). Such relativemovement between the clip and housing could occur for example becausethe clinician may not realize that the locking clip has been put intothe binding orientation and thus the clinician might continue towithdraw the needle cannula (i.e., pull on the needle hub in theproximal direction). As more particularly described in the '073publication, the interior structure of the housing and the structure ofthe locking clip are respectively designed and arranged so the forcesecuring the locking clip to the needle cannula is increased if suchrelative movement causes the locking clip to come into contact withportions of the housing interior structure.

Referring to FIGS. 1-3C of the present application, there is disclosed asafety shield assembly that includes a housing 644 and a clip 628according to a first exemplary embodiment of the present invention. Thesafety shield assembly is a protective device that includes the housing644 for receiving the locking clip 628, where the clip 628 isaccommodated in a cavity of the housing. The components of the safetyshield assembly can be fabricated from materials suitable for medicalapplications, for example, polymerics or metals, such as stainlesssteel, depending on the particular medical application and/or preferenceof a clinician. Semi-rigid and rigid polymerics are contemplated forfabrication, as well as resilient materials. However, one skilled in theart will realize that other materials and fabrication methods suitablefor assembly and manufacture, in accordance with the present disclosure,also would be appropriate.

A needle cannula 22 or similar piercing member is received through acentral bore in the housing 644 of the safety shield assembly. Theneedle cannula 22 has a hub (not shown), a distal end 26 and defines alongitudinal axis x. It is contemplated that the needle cannula 22 maybe fabricated from stainless steel in a range of sizes, including butnot limited to, about 14 to 26 gauge, although smaller or larger sizescan be used depending on the requirements of a particular application.The needle cannula 22 can be provided in various lengths, for example,about 2.6 to 4.1 inches, although smaller or larger sizes also areenvisioned.

Examples of clips 628 and 728 suitable for use as a locking clip in thevarious embodiments of the present disclosure, for example, as the clip628 depicted in FIGS. 1-2D, are shown in FIGS. 10 and 11. Like referencenumbers are used to denote like components in the various figures asprovided herein. In one embodiment, the clips 628 and 728 each aremonolithically formed as a single integral piece of metal.

Referring to FIGS. 1-2D and 10, the clip 628 includes an aperture platesection 660 that defines the aperture 630. The aperture plate 660 has arectangular, generally planar configuration with sufficient stiffness toproduce forces for binding the clip to the needle cannula 22. The clip628 also is disposed for rotational movement of the aperture plate 660between a sliding orientation (FIG. 1), corresponding to axis y and abinding orientation (FIG. 2A), corresponding to an inclination arelative to axis y. The aperture 630 is dimensioned for slideablemovement of the cannula therethrough and is oriented in an axis y whichas shown is approximately perpendicular to the longitudinal axis x. Inits sliding orientation, the aperture plate is oriented so that theedges of the aperture do not interfere with the sliding of the needlecannula 22 through the aperture. In other words, the aperture plate 660is oriented so it crosses the longitudinal axis x at an angle thatallows such slideable movement by the cannula.

In the binding orientation, the aperture plate 660 is rotated such that,when in the binding orientation, it is inclined to the inclination awith respect to the axis y, and thus also would be inclined with respectto the longitudinal axis x of the needle cannula. In the bindingorientation, the edges of the aperture forcibly contact the outersurface of the needle cannula and prevent further sliding of the needlecannula through the aperture 630.

The clip 628 includes a first leg 632 that defines another aperture,such as for example, a trigger hole 634 dimensioned for movement of theneedle cannula 22 therethrough (see FIG. 10). The first leg 632 has adistal part 636 that is configured to engage the catheter 38. The clip628 includes a second leg 640 having a bearing surface 642 that engagesneedle cannula 22. The first leg 632 and second leg 640 are resilientlybiased for convergent movement such that, when the distal end 26 orsharp tip of the needle cannula 22 is withdrawn from the trigger hole634, the clip converges and the aperture plate 660 rotates until theaperture 630 is disposed in the binding orientation/position and thedistal part 636 disengages the catheter 38 (see FIG. 2A). The first leg632 also rotates in the plane of the clip, to the position shown in FIG.2A.

The second leg 640 includes a network 641 (FIG. 10) that forms acontinuous spring element to facilitate the resilient bias of the firstand second legs 632, 640 and the resultant rotation of the apertureplate 660 and the first leg 632, and also exerts the force which causesthe edges of the aperture 630 to contact the surface of the needlecannula and prevent further sliding of the needle cannula through theaperture 630. The network 641 is resiliently biased and includes biasingelements, such as, for example, spring elements that are connected toform a continuous network and may include channels therebetween (seeFIG. 10). In effect, the network simulates an elongated spring lever armwhile utilizing a much smaller space to contain the lever arm. Thisconfiguration advantageously provides more resilience without requiringadditional material for fabrication, thereby improving manufacturingefficiency. The network 641 also reduces the stress concentrations onthe clip 628, due to the continuous design, and reduces drag on theneedle cannula 22 as it is withdrawn towards the trigger hole 634. Thenetwork 641 may include one or more spring elements,

The housing 644 contains the clip 628, and the housing 644 can includean outer surface, a top section, and a bottom section (see, e.g., FIGS.1 to 2D). The housing 644 is movable between a retracted position and anextended position.

In the sliding orientation, as shown in FIG. 1, the first leg 632extends distally from aperture plate 660. The first leg 632 has aproximal part 664 (FIG. 10) that is perpendicularly oriented relative toaxis y of aperture plate 660 (see FIG. 10). The distal part 636 of thefirst leg 632 includes a transverse portion 667 that defines an apertureor trigger hole 634. The aperture or trigger hole 634 is formed withinthe transverse portion 667 for slideable engagement with the needlecannula 22 during movement between the retracted position and theextended position of the housing 644.

In the sliding orientation, the needle cannula 22 is disposed in theaperture or trigger hole 634 to prevent such convergent movement of thefirst leg 632. The distal part 636 defines an arm 668 that is configuredto releasably retain the catheter hub with the outer surface of thehousing 644. In the sliding orientation, the arm 668 is disposed suchthat a hook portion 670 thereof captures a flange 72 of the catheter hub(see FIG. 1).

As provided in International Publication No. WO 2005/042073, and in thepresent invention, first and second legs 632 and 640 are biased forconvergent movement, which causes the first leg 632 to move transverseto the longitudinal axis x. While a portion of the first leg 632 doesmove traverse the axis of the needle cannula 22 in the course of itsmovement, the plane of movement of the first leg 632 is substantiallyparallel to the needle cannula 22, more particularly in a plane that issubstantially parallel to and along the longitudinal axis x of theneedle cannula. In other words, the needle cannula 22 actually lies inthe plane of movement of the first leg 632. The same is true of thedistal part 636 and the hook portion 670 of the first leg 632.

As shown in FIG. 2A, when the needle cannula 22 is withdrawn from theaperture forming the trigger hole 634, the distal part 636 rotates dueto the bias of the first and second legs 632, 640 until the apertureplate 660 reaches the binding orientation. The hook portion 670 alsorotates away from the catheter hub or needle cannula 22, as shown inFIG. 2A, to release the flange 72 of the catheter hub. The catheter 38is then separable from the housing 644.

The distal part 636 also includes a clearance opening 635 disposedadjacent to the distal end 26 of the needle cannula 22. In the bindingorientation, the distal end 26 is in alignment with the clearanceopening 635 as illustrated in FIG. 2A. Also, and depending upon a numberof factors such as the diameter of the needle cannula 22, the sharp tipat the distal end 26 of the needle cannula 22 may extend through theclearance opening 635. In addition, in the binding orientation thedistal end 26 of the needle cannula 22 is spaced from the clearanceopening 635 such that the distal end does not contact the inner surfacesof the clearance opening 635. In other words, the clearance opening 635has a size that is greater than the diameter of the needle cannula 22.

Thus, the clearance opening 635 and the distal part 636 of the clip 628do not block or impede the travel of the needle cannula 22 in a distaldirection when in the binding configuration. As also indicated above, inat least some cases, the sharp tip 26 of the needle cannula 22 sticksout of the distal part 636 of the clip 628.

In the sliding orientation, the bearing surface 642 engages the outersurface of the needle cannula 22 to balance the convergent spring forcesgenerated by the first and second legs 632, 640 and the network 641 ofspring elements. Correspondingly, the first and second legs 632, 640 arebalanced about the needle cannula 22 such that the aperture 630 of theaperture plate 660 is maintained in a sliding orientation. In thebinding orientation, the needle cannula 22 passes out of the aperture ortrigger hole 634 and the bearing surface 642 facilitates inclination ofthe clip 628. As the first and second legs 632, 640 converge due to theresilience of the spring elements of the network 641, the bearingsurface 642 engages the needle cannula 22, causing the clip 628 torotate relative to the longitudinal axis x (i.e., relative to thelongitudinal axis of the needle cannula), putting the aperture 630 intothe binding orientation with the needle cannula 22. The bearing surface642 also engages the needle cannula 22 in the binding orientation toprevent movement of the needle cannula in the proximal and distaldirections.

This binding configuration advantageously provides a bi-directional lockthat locks the distal end 26 of the needle cannula 22 in a protectedconfiguration. As can be seen from FIGS. 1-2A, the above configurationof the clip 628 also does not require operative engagement with thehousing 644 to actuate the protective features of the clip.

The clip 628 also includes a transition portion 676 (FIG. 10) thatconnects the aperture plate 660 with the first leg 632. The transitionportion 676 is configured to engage an inner surface 678 (FIG. 2B) ofthe housing 644 in the case where a clinician attempts to move thehousing in a distal direction and/or withdraw the locked needle from thehousing in a proximal direction, as illustrated in FIG. 2B. Inparticular embodiments, the inner surface 678 is disposed in parallelalignment with axis y. Such engagement of the transition portion 676 andthe housing inner surface 678 augments the gripping engagement of theaperture 630 with the needle cannula 22 (e.g., the force locking theclip 628 to the needle cannula 22 is increased).

Similarly, the housing 644 includes internal structures 680,682 that canbe configured to engage correspondingly adjacent portions of the clip628. For example, as shown in FIG. 2C, if the housing 644 happens to bepushed backwardly toward the hub of the needle (i.e., in the proximaldirection), or if the needle 22 and clip 628 in the bindingconfiguration are thrust forward in the housing 644 (i.e., in the distaldirection), the clip 628 engages the internal structure of the housing644 to prevent further forward movement of the clip 628 and the needlecannula 22, as well as re-exposure of the distal end 26.

The position of the clearance hole and/or the vertical dimension of theclearance hole 635 is adjusted so the distal end of the needle cannulaor the needle is disposed in or opposite to the clearance opening whenin the binding orientation. Since the size of the clearance opening islarger than the diameter of the needle, the first leg does not form abarrier to movement of the distal end of the needle in any direction.Thus, when the clip is in either the sliding configuration or thebinding configuration, axial movement of the needle is neither blockednor impeded by the trigger hole 634 or the clearance opening 635. Also,the distal end 26 of the needle remains spaced from the clearanceopening 635 when the clip 628 is in the binding orientation even in thecase where the user pushes backward on the housing 644, or forward onthe needle hub.

As described above, when the clip 628 is in the binding orientation theclip forms a bi-directional lock that secures the clip to the needlecannula 22 so that there is essentially no relative movement between theclip and the needle cannula. The transition of the clip 628 from thesliding orientation to the binding orientation establishes the primarylocking mechanism. Such a bi-directional lock formed by the clip incombination with the internal structure 678 (FIG. 2B), 680,682 of thehousing 644 provides a secondary guard against relative motion of thedistal end 26 of the needle cannula 22 in either the proximal or distaldirections. In this way, the sharp distal end 26 of the needle cannula22 is prevented from exiting the housing 644, and thus from becomingre-exposed.

As also described above, the internal structure of the housing 644 alsois arranged and configured so that contact between such housingstructure 678, 680, 682 and the clip 628 does not cause the clip tobecome disengaged from the exterior surface of the needle cannula 22,thereby maintaining the bi-directional lock. In this way, relativemovement between the needle cannula 22 and the housing 644 in either thedistal or proximal directions does not cause the clip 628 to becomedisengaged from the needle cannula exterior surface. Thus, thesestructures 678, 680, 682 of the housing 644 and the clip 628 form asecondary mechanism or guard against the distal end 26 of the needlecannula 22 from becoming re-exposed.

In further embodiments of the safety shield assembly, see e.g., FIGS. 2Dand 3A-3C, the needle cannula 22 is provided with a safety stop feature50 (and alternatively 50 b and 50 c) that is near or adjacent to thedistal end 26 of the needle cannula 22. The safety stop feature 50 isprovided to deal with a highly unlikely situation where, due tointentional acts or unexpected contacts or impacts, a condition (i.e., atransient condition, force or load) is created after the bindingorientation has been achieved between the clip and the needle cannula.Such a condition also would be of such a nature so as to cause the clip628 and the needle cannula 22 to be capable of moving with respect toeach other (i.e., so the needle cannula can move relative to the clipand the housing 644), thereby allowing further motion of the needlecannula in the proximal direction and/or motion of the housing in thedistal direction.

In the case where such a condition was created, thereby allowing suchrelative proximal movement of the needle cannula 22 with respect to thehousing to occur, then such relative proximal movement would berestrained in one of two ways: re-establishing the binding orientationbetween the clip and needle cannula, or when the safety stop featurecontacts the clip aperture plate. If the safety stop feature has notcontacted the aperture plate and the transient condition has dampened orabated sufficiently, then the clip and the needle cannula return to thebinding orientation (i.e., bi-directional lock re-established), therebypreventing further relative movement between the clip and the needlecannula.

If the relative proximal movement of the needle cannula 22 causes thesafety stop feature 50 to contact the aperture plate 630 such as shownin FIG. 2D, the increased diameter of the needle cannula in thehorizontal direction prevents further movement of the needle cannula inthe proximal direction. However, in that case the reduced diameter ofthe needle cannula in the vertical direction prevents the upper andlower edges of the aperture 630 from binding or grasping the needlecannula. Thus, while the stop feature 50 is in contact with the sides ofthe aperture 630, the needle cannula and the clip are not in a bindingconfiguration.

If a force is applied to the clip or the needle which would impartdistal movement of the needle relative to the clip, the stop featuredoes not prevent such movement. Rather, the needle moves to the pointwhere the stop feature no longer contacts the sides of the aperture. Atthat point, however, the top and bottom edges of the aperture 630 willre-engage the top and bottom surfaces of the needle cannula, thusre-establishing a binding configuration and preventing further distalmovement of the needle cannula relative to the clip. Thus, the safetystop feature 50 does not prevent or effect movement of the needle withinthe clip in the relative distal direction.

As shown in FIGS. 2A-2C, the safety stop feature 50 does nothing toblock or not contact the aperture plate 630 or other clip or housingstructure so as to restrain motion of the needle cannula 22 in thedistal direction and/or motion of the housing 644 in the proximaldirection (i.e., a bi-directional lock is not created between the safetystop feature and the aperture plate). Nor is there any other change inshape of the needle which prevents or effects such relative distalmovement of the needle relative to the clip. Only the bindingconfiguration of the top and bottom edges of the aperture 630 preventssuch relative distal movement.

In general terms, the safety stop feature 50 is formed of one or moreprojections 52 (see FIG. 3A) that extend generally outwardly from theexterior surface of the needle cannula 22. These one or more projectionsare sized and arranged so that they create a radial projection from theneedle cannula exterior surface such that the horizontal width of theneedle cannula in this region becomes larger than the aperture 630 inthe aperture plate 660. In particular, the safety stop feature 50 is alocalized depressed or flattened area 54 (FIG. 3A) in the needle cannula22, a portion of which extends generally outwardly from the exteriorsurface of the needle cannula. Such a portion thereby forms the one ormore projections 52. Such a localized depressed or flattened area 54 canbe formed, for example, by crimping the needle cannula 22.

When the clip 628 is activated so as to be in the binding condition ororientation, the needle cannula 22, including the safety stop feature50, is withdrawn into the housing 644 and the safety stop feature isspaced from the aperture plate 660 (see FIG. 2A). It should berecognized that the safety stop feature 50 is not designed or intendedto engage with or trigger the trigger hole 634 or any part of the clipso as to cause the clip to bind to the needle cannula (i.e., safety stopfeature passes through the trigger hole without triggering the clip628). As also shown in FIGS. 2B and 2C, the safety stop feature 50 alsois spaced from the aperture plate 660 when there is relative movementbetween the housing 644 and the needle cannula 22 in either proximal ordistal directions and when the clip 628 is in the binding orientation.

In sum, the bi-directional lock formed by the clip 628 itself forms theprimary mechanism preventing the sharp tip or distal end 26 of theneedle cannula 22 from being re-exposed, where the external structure ofthe housing 644 is the structure that prevents a clinician fromcontacting the sharp distal end 26 of the needle cannula 22. The housinginternal structure and the clip structure are such as to prevent theclip 628 from becoming disengaged and thus form a secondary mechanismagainst the distal end 26 of the needle cannula 22 from becomingre-exposed. The needle cannula safety stop feature 50, in combinationwith the clip 628, forms a third mechanism whereby relative proximalmotion of the needle cannula with respect to the housing 644 does notlead to re-exposure of the sharp distal end 26 of the needle cannula 22.

According to another exemplary embodiment, and with reference to FIG.3B, an arcuate member(s) 50 b (e.g., ferrule or ring) is secured aboutthe exterior surface of the needle cannula, thereby forming the safetystop or feature. Although the arcuate member is depicted as beingcontinuous about the circumference of the needle cannula, this is not alimitation as it is contemplated that one or more arcuate members aresecured at different locations about the circumference and so eacharcuate member extends along a portion of the circumference. Also, infurther embodiments, and as shown in FIG. 3B, the leading edge of thearcuate member can be tapered or otherwise form a sloping surface;however, the leading edge can be essentially perpendicular to theexterior surface of the needle cannula. Each of the arcuate membersshall have an arc length, height and axial length sufficient so that themember engages the aperture 630 and stops further movement of the needlecannula and/or locking clip with respect to each other.

According to another exemplary embodiment, and with reference to FIG.3C, one or more axially extending members 50 c (e.g., rail like ferruleor ring) are secured to the exterior surface of the needle cannulathereby forming the safety stop or feature. In further particularembodiments, two or more axially extending members are provided andlocated so as to be equally spaced from each other about thecircumference of the needle cannula. For example, a pair of axiallyextending members are provided and spaced from each other by about 180degrees, three axially extending members are provided that are spacedfrom each other by about 120 degrees or four axially extending membersare provided that are spaced from each other by about 90 degrees. Also,in further embodiments, and as shown in FIG. 3C, the leading edge ofeach axially extending member can be tapered or otherwise form a slopingsurface; however, the leading edge can be essentially perpendicular tothe exterior surface of the needle cannula. Each of the axiallyextending members shall have a width, height and axial length sufficientso that the member engages the aperture 630 and stops further movementof the needle cannula and/or locking clip with respect to each other.

In further exemplary embodiments, the safety stop includes a dimplehaving a diameter or at least a portion thereof larger than the aperturehole affixed or formed in the exterior surface of the needle cannula(e.g., a dimple formed by deposition of a soldering material or adhesivematerial) to prevent proximal movement of the distal end of the needlecannula 22 through the aperture hole 630. Further, the safety stop canbe formed with at least two such dimples that are sized greater than thediameter of the needle cannula 22, where the dimple 50 should have adiameter larger than the aperture 630. The foregoing are exemplary andshall not be construed as limiting the safety stop to the specificexamples illustrated and/or described herein.

A second example of a clip is shown in FIG. 11, where the clip 728 issimilar in structure to the clip 628 depicted in FIG. 10. For example,the clip 728 includes first and second legs 732 and 740, and an apertureplate 760 defining an aperture 730. The first leg 732 includes a distalportion 736 that terminates in a hook portion 770 for capturing a flange72 of the catheter hub. The first leg 732 includes a trigger hole 734dimensioned for movement of the needle cannula therethrough in a slidingorientation. Extending in the proximal direction from the trigger hole734 is a clearance opening 735 configured and arranged to receive theneedle cannula in a binding orientation. The first and second legs 732and 740 are resiliently biased for convergent movement by virtue of anetwork 741 of spring elements.

According to the clip 728 depicted in FIG. 11, the trigger hole 734 andthe clearance opening 735 substantially overlap each other. In contrast,the clip 628 depicted in FIG. 10 has a separate trigger hole 734 andclearance opening 735, i.e., a two-hole design without any overlap. Thisarrangement is similar to that shown in International Publication No. WO2005/042073.

FIGS. 4A to 9 depict a second exemplary embodiment or aspect of thepresent disclosure, in which a trigger bushing component is providedalong with a needle cannula having a stop feature. The second exemplaryembodiment of FIGS. 4A to 9 functions in a manner similar to the firstexemplary embodiment of FIGS. 1-3C, but where the trigger bushingcomponent and the stop feature cooperate as herein described to causethe triggering of the locking clip so the locking clip transitions formthe sliding orientation to the binding orientation. Also, and asdescribed herein, in the second exemplary embodiment, the triggerbushing component is sized so that it contacts the housing 644 of thesafety shield or contacts the aperture/locking plate, thereby preventingwithdrawal of the distal end of the needle cannula through the aperturein the aperture/locking plate when the locking clip is in the bindingorientation.

Referring to FIGS. 4A-4B, a trigger bushing 60 is generally tubular inconfiguration, and is placed in the trigger hole 734 of the clip 728when the clip is in the sliding orientation. For illustration purposes,in FIGS. 4A to 9, the clip 728 depicted in FIG. 11 has been selected asthe locking clip, although the clip 628 of FIG. 10 could be substitutedtherefor, in accordance with the present disclosure. In embodimentsutilizing a needle having a stop member and a trigger bushing, thetrigger bushing 60 can be placed in the trigger hole 734, and then theneedle cannula 22 is inserted through the aperture 730 of theaperture/locking plate 760 and through a lumen of the trigger bushing.

As shown in FIGS. 4A-4B, the clip 728 and safety shield are provided inthe sliding orientation, such that the needle cannula 14 can slideeasily through the housing 644 of the safety shield. The trigger bushing60 is provided to fit within the trigger hole 734 in the slidingorientation, and has an inner diameter greater than the outer diameterof the needle cannula 22, allowing the needle cannula 22 to slide in thelumen therethrough in the sliding orientation. In particularembodiments, the trigger bushing 60 is retained within the trigger holeso that it does not generally move axially when the locking clip is inthe sliding orientation.

Similar to the first exemplary embodiment of FIGS. 1-3C, the stop member50 provided on the needle cannula 22 in the second exemplary embodimentshould be sized so as to prevent passage of the distal end 26 of theneedle cannula 22 through the lumen in the trigger bushing 60. The stopmember 50 also should have a diameter or portion thereof larger than thelumen and smaller than the trigger hole 734. In the second exemplaryembodiment, the stop member does not contact the aperture/locking plate.

In the sliding orientation of FIGS. 4A-4B, when the needle cannula 22 ispulled back and withdrawn through the trigger hole 734, it slides withinthe trigger bushing until the stop member 50 contacts the triggerbushing 60. Thereafter, further movement of the needle cannula 14 in theproximal direction also causes the trigger bushing 60 to slide withinthe trigger hole 734 in the proximal direction. When a distal end of thetrigger bushing 60 is pulled back through the trigger hole 734, thelocking clip 728 moves into the binding orientation, as depicted inFIGS. 5A-5B.

In the binding orientation of FIGS. 5A-5B, the distal end 26 of theneedle cannula 22 is disposed in the clearance opening 735. In thisstate, a bi-directional lock is engaged, thereby restraining movement ofthe needle cannula 22. As shown in FIGS. 5A-5B, the aperture plate 760is inclined relative to the sliding orientation of FIGS. 4A-4B, and thebearing surface 742 facilitates inclination of the clip 728. Resistanceto re-exposure of the needle cannula 22 is provided due to the presenceof the aperture/locking plate 760, in which the aperture engages withthe exterior surface of the needle cannula thereby forming thebi-directional lock.

Proximal motion of the needle cannula 22 is resisted through at leastthree mechanisms. The bi-directional lock provides the primary guardagainst motion of the distal end 26 of the needle cannula 22 in eitherthe proximal or distal directions. The secondary guard against suchmotion in either the proximal or distal direction is the structure ofthe interior of the housing and the structure of the locking clip. Suchstructures cooperate so distal or proximal motion of the needle cannuladoes not cause the locking clip to disengage from the needle cannulaexterior surface. As indicated herein, the present disclosure includes asafety stop mechanism that prevents the needle tip from becoming exposedin the case where one conceived of a means that would allow the lockingclip and needle cannula to move with respect to each other therebyallowing further motion of the needle cannula in the proximal directionand/or motion of the housing in the distal direction. As describedbelow, at least one of the following two mechanisms can be provided inconjunction with the safety shield to stop such further unwantedmovement of the distal end of the needle cannula in the proximaldirection.

FIGS. 6 and 7 depict different views of a first mechanism for preventingfurther proximal movement of the distal end 26 of the needle cannula 22.As shown in FIG. 6, the trigger bushing 60 moves back until it contactsthe aperture/locking plate 760. In this case, the diameter of thetrigger bushing 60 is greater than the aperture 730 and thus, the distalend 26 of the needle cannula 22 is prevented from moving through theaperture 730. Therefore, the presence of the stop member 50 and thetrigger bushing 60 abutting against the aperture/locking plate 760provides a physical barrier to block further proximal movement of thedistal end 26 of the needle cannula 22. As a result, the distal end ofthe needle and the needle tip are prevented from moving proximallybeyond the aperture and thus out of the housing.

FIGS. 8 and 9 depict different views of a second mechanism forpreventing further proximal movement of the distal end 26 of the needlecannula 22. As shown in FIG. 8, the trigger bushing 60 moves back untilit contacts a portion 62 of the housing 664 making up the safety shield.Because the trigger bushing 60 is against at least the portion 62 of thehousing, the distal end 26 of the needle cannula 22 is stopped fromfurther proximal movement. Therefore, the presence of the stop member 50and the trigger bushing 60 abutting against or contacting the portion 62of the housing provides a physical barrier to block further proximalmovement of the distal end 26 of the needle cannula 22. Accordingly, thedistal end and the needle tip cannot move proximally out of the housing.

In view of the foregoing, in a further embodiment, when the needlecannula includes a safety stop member such as that shown in FIG. 1, thesafety shield housing is configurable so that the safety stop membercontacts at least a portion of the housing thereby essentiallypreventing the distal end 18 of the needle cannula from moving furtherproximally. Accordingly, the distal end and the needle tip cannot moveproximally beyond or out of the housing.

As described in the above exemplary embodiments of the safety shield,the needle cannula or other piercing member can be provided with atleast a safety stop member, or at least a stop member and triggerbushing such that in a binding orientation, further movement of a distalend of the needle cannula in the proximal direction is essentiallyprevented. According to the present disclosure, the safety stop memberand/or the trigger bushing abut against either the aperture/lockingplate or a portion of the safety shield housing. In this way theaperture/locking plate or the housing provide a physical barrier toblock further proximal motion of the needle and thus the needle point.The present disclosure also encompasses methods of forming the safetystop member/feature or the stop member/feature on the needle cannula,and inserting the trigger bushing in the trigger hole, and methods ofusing a safety shield provided in accordance with the above-describedfeatures.

Although embodiments of the disclosure have been described usingspecific terms, such description is for illustrative purposes only, andit is to be understood that changes and variations may be made withoutdeparting from the spirit or scope of the following claims.

INCORPORATION BY REFERENCE

The entire contents of all patents, published patent applications andother references cited herein are hereby expressly incorporated hereinby reference in their entireties.

What is claimed is: 1-23. (canceled)
 24. A method of using a safetyshield incorporating a clip, comprising: positioning a needle through acatheter hub, a trigger hole defined within a first leg of a body of theclip, and an aperture defined in the body of the clip between a secondleg of the body of the clip and the first leg of the body of the clip;maintaining the clip in a sliding orientation; connecting at least aportion of the clip to the catheter hub; withdrawing the needle from thecatheter hub and through the trigger hole to allow the first and secondlegs to converge such that the portion of the clip connected to thecatheter hub becomes disconnected from the catheter hub and the clipmoves into a binding orientation in relation to the needle; andpreventing the needle from withdrawing through the aperture by providinga stop member on the needle.
 25. The method of claim 24, whereinpreventing the needle from withdrawing includes preventing movement ofthe needle through the aperture with at least a dimple of the stopmember.
 26. The method of claim 24, further including positioning atrigger bushing about at least a portion of the needle, the triggerbushing being sized larger than the aperture.
 27. The method of claim26, wherein positioning the needle includes positioning the triggerbushing between the stop member and the aperture.
 28. The method ofclaim 26, further comprising abutting the trigger bushing against thebody of the clip to prevent withdrawal of a distal end of the needlethrough the aperture.
 29. The method of claim 24, wherein connecting theclip includes releasably engaging the catheter hub with a hook portionof the clip when the clip is in the sliding orientation.
 30. The methodof claim 24, further comprising biasing the first and second legs of theclip for convergent movement with a spring member of the second leg ofthe clip.
 31. The method of claim 24, further comprising contacting theneedle with a bearing surface of the second leg of the clip.
 32. Themethod of claim 24, further comprising positioning the needle in aclearance opening defined in the first leg adjacent to the trigger holeas the clip moves into the binding orientation.